Completed PHASE3 INTERVENTIONAL 4-arm NCT02016716

A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With Osteoporosis

Sponsor: Amgen

Conditions Postmenopausal Osteoporosis

Interventions Placebo 70 mg/mL Placebo 90 mg/mL Romosozumab 70 mg/mL Romosozumab 90 mg/mL

Updated 9 times since 2017 Last updated: Oct 11, 2018 Started: Dec 3, 2013 Primary completion: Sep 8, 2014 Completion: Dec 8, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02016716, this PHASE3 trial focuses on Postmenopausal Osteoporosis and remains completed. Sponsored by Amgen, it has been updated 9 times since 2013, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Dec 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 4 earlier versions

Jun 2018 — Dec 2018 [monthly]

Completed PHASE3
Jul 2017 — Jun 2018 [monthly]

Completed PHASE3
Feb 2017 — Jul 2017 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Dec 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Amgen

Data source: Amgen

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Bethesda, United States , Brno, Czechia , Gainesville, United States , Gdynia, Poland , Gliwice, Poland , Katowice, Poland , Klatovy, Czechia , Krakow, Poland , Uherské Hradiště, Czechia , Warsaw, Poland and 2 more locations